The Honorable Kathleen Sebelius — Page 2

Because of the challenge and pursuant to 42 CFR § 83.18(b), you appointed a panel of three
Department of Health and Human Services (HHS) personnel, independent of the National
Institute for Occupational Safety and Health (NIOSH), to conduct an administrative review and
provide recommendations concerning the merits of the challenge and the resolution of the issues
contested by the challenge. The undersigned, Steven L. Simon, PhD, C. Norman Coleman, MD,
and Orhan Suleiman, PhD, comprise that panel. Our collective expertise includes radiation
medicine, health physics, radiation exposure, dose assessment and dose reconstruction, and
radiation risk analysis. We were charged with conducting an administrative review of your
determination not to add a class of Bliss & Laughlin employees to the SEC, which included
reviewing the data and information that formed the basis of your decision. Pursuant to 42 CFR §
83.18(b), we considered whether HHS substantially complied with the regulatory procedures set
out in 42 CFR part 83 and whether the Secretary’s final decision was supported by accurate
factual information, and we also reviewed the principal findings and recommendations of
NIOSH and the Board. As explained below, we concluded that petitioners’ challenge to your
decision is without merit, and we do not recommend any change to your decision to deny adding
a class of Bliss & Laughlin employees to the SEC.

In conducting our review, pursuant to 42 CFR § 83.18(b), we examined the views and
information submitted by the petitioners in the challenge, the NIOSH evaluation report, the
report containing the recommendations of the Board, the recommendations of the Director of
NIOSH to the Secretary, information presented or submitted to the Board, and the deliberations
of the Board prior to the issuance of its recommendations, Since 42 CFR § 83.18(a) prohibits
petitioners from introducing any new information or documentation, our review was based
entirely on the administrative record in this case, as described above.

A memorandum to you, dated May 4, 2011, from the Director of NIOSH, which was initialed by
the Director of the CDC and which you approved and signed, states that NIOSH concluded that
there were sufficient data to perform individual dose reconstructions for the Bliss & Laughlin
class of employees. This conclusion was based on the NIOSH Evaluation Report, which
evaluated the feasibility for completing dose reconstructions for all Atomic Weapons Employees
who worked at the Bliss & Laughlin Stee! Company in Buffalo, New York, for the operational
period from January 1, 1951, through December 31, 1952, and for the residual contamination
period from January 1, 1953, through December 31, 1998. Specifically, this memorandum states
as follows:

1, NIOSH determined that the principal source of internal radiation doses for the class
evaluated was from the inhalation and ingestion of uranium particles in the dust
generated by the machining and handling of uranium metal, and the principal source of
external radiation doses were from deposition of uranium particles in the dust from the
machining of uranium rods and the direct handling of uranium.

2. NIOSH found that the available monitoring records, process descriptions, and source-
term data and alternative data sources are adequate to complete internal and external dose
reconstruction with sufficient accuracy for the evaluated class of employees.



*" RECEIVED "*"
Jul 19,2011 11:49:57 WS# 20
OSNUM: 071920111060
OFFICE OF THE SECRETARY
CORRESPONDENCE
CONTROL CENTER

SEC Tracking Number: SEC00131

July 13, 2011

Dawn L. Smalls

Executive Secretary to the

Department of Health and Human Services
200 Independence Ave. SW #603H
Washington, DC 20201

Dear Ms. Smalls:

As per your letter, we are requesting an Administrative Review of this Secretary’s final
determination eliminating the Bliss and Laughlin Employees to the SEC.

We understand that some employees from Bliss and Laughlin have been compensated but
others have not. How was this determined? Why were the specifics of other approvals
withheld from us? Ail employees assigned, worked in the same area at the same time.
Please note that our father, was the authorative figure who activated
the Bliss and Laughlin Security System, permitting employees to enter the Mill on days
of the uranium runs. He was responsible for all these employees scheduled to work on
the rods. He remained among these employees for their entire work shifts, and then
activated the Security System at the Bliss and Laughlin Plant at closings, Also, he was
resvonsible for supervising the runs on the floor with all Milt employees. He arrived
before them, remained throughout their entire shifts and left after them.

In vour Determination Findings it states that NIOSH found the monitoring records.
Previous correspondence has repeatedly stated that no records were available.

Now you state that monitoring records exist and are instrumental in making your
decision. How did these records suddenly appear? How were they obtained? How were
they used by you? What technology, possibly outdated, did they employ in the
monitoring process? How was it determined that these records are accurate? Who


The Honorable Kathleen Sebelius - Page 4

reconstructions may use monitoring results for groups of workers with comparable
activities and relationships to the radiation environment. Alternatively, workplace area
monitoring data may be used to estimate the dose.” The data from the report
BattelleTBD-6000, are relevant and, thus, are allowed by law as a substitute for
individual monitoring data. Moreover, as explained in the second point above, the highest
values were chosen so as to give the largest estimate of radiation dose to the claimant.

4. The fourth point above indicates that NIOSH believed it has access to sufficient
information to bound internal and external dose for all members of the evaluated class.
This panel agrees with this conclusion. In addition, as noted above, NIOSH has used data
that has maximized the estimation of dose to and all other members of the
evaluated class (thus resulting in the largest credible value of the Probability of
Causation, a situation in favor of the claimant).

5, The fifth point above describes the use of ORAUT-OTIB-0006, Dose Reconstruction
from Occupationally Related Diagnostic X-Ray Procedures. Based on our accumulated
experience, we know that dose records from diagnostic x-ray procedures during this
period of time were rarely calculated, if at all. Moreover, such diagnostic x-ray doses
would have been small, were necessary for health maintenance, and in our opinion, not
materially significant to the health risk of the worker. In any case, ORAUT-OTIB-0006
cited above would be adequate for dose reconstruction, particularly since the methods
described in this document, as in other NIOSH dose reconstruction strategies for
compensation purposes, made conservative assumptions that maximized the possible
dose received.

Jn our review of this case, we have concluded:
1. HHS complied with the regulatory procedures set out in 42 CFR part 83.
2. Your decision contained no evidence of factual error and was supported by factually
accurate information.
3, There were no errors of fact or omission in the principal findings and recommendations
of NIOSH and the Advisory Board.

In summary: Based upon our review of the administrative record in this case, this panel believes
that the regulatory procedures have been complied with in making your decision, that credible
sources of information have been used as allowed for under EEOICPA implementing regulations
42 CFR parts 82 arid 83, and that you, NIOSH, and the Advisory Board came to reasonable and
appropriate conclusions. In short, we have concluded that petitioners’ challenge to your decision
is without merit, and we see no reason to recommend any change to your decision to deny adding
a class of Bliss & Laughlin employees to the SEC.

As an administrative review panel, we are also concerned about providing a full and satisfactory
response to the petitioners. We believe their concerns are legitimate and serious and deserve full
attention. Although we cannot answer the questions raised in the petitioners’ appeal letter that



The Honorable Kathleen Sebelius — Page 3

3. NIOSH obtained process information and air monitoring data collected during the rod-
turning operations, and has assessed Battelle-TBD-6000 and monitoring data bounding
similar operations at other sites sufficient to bound internal and external dose.

4. NIOSH determined that it has access to sufficient information to bound internal and
external dose for all members of the evaluated class.

5. Although no records have been identified that indicate that occupational medical X-rays
were required during the operational period, the dose associated with X-ray exams can be
assessed using the methodology defined in ORAUT-OTIB-0006, Dose Reconstruction
from Occupationally Related Diagnostic X-Ray Procedures.

In that memorandum, NIOSH concluded that it has access to sufficient Bliss & Laughlin
information to either (1) estimate the maximum external and internal radiation dose for every
type of cancer that could have been incurred under plausible circumstances by any member of
the evaluated class; or (2) estimate the external and internal radiation doses to members of the
evaluated class more precisely than a maximum dose estimate.

With respect to the five points above as enumerated by NIOSH and the conclusions which they
supported, we provide the following comments as part of our administrative review:

1. With regard to the first point, this panel strongly agrees that the principal source of
internal radiation doses was from the inhalation and ingestion of uranium particles and
that the principal sources of external radiation doses would have been from the deposition
of uranium particles in the dust from the machining of uranium rods and the direct
handling of uranium.

2. With regard to the second point that the available records and alternative sources are
adequate to reconstruct doses with sufficient accuracy, this panel agrees that the available H
records and alternative sources selected were adequate, Regulations implementing
EEOICPA specifically allow for various types of data to be used in reconstructing dose.

Here it is useful to note that for the purposes of inhalation dose calculations, NIOSH used
the largest reported average value.from air sampling at facilities that machined uranium
(see Battelle-TBD-6000, rev0, Table 7.5, p.46). The value of 5480 dpm/m? for the job
category of “Centerless Grinder” was the highest value in the table and would give the
highest inhalation dose. This is clearly an estimate representing a “worst case condition”
and would result in the highest credible dose estimate.

3. With respect to the third point above, this panel agrees that air monitoring data collected
during the rod-turning operations, assessed in Battelle-TBD-6000, and monitoring data
bounding similar operations at other sites were all sufficient to bound internal and
external dose. It is our understanding that NIOSH relied on data from the Battelle-TBD-
6000 report which was a comprehensive report on “Site Profiles for Atomic Weapons
Employers that Worked Uranium and Thorium Metals.” We note that EEOICPA
regulations allow for the use of workplace monitoring data. Specifically, 42 CFR §
82.2(b) states that: “If individual monitoring data are not available or adequate, dose



The Honorable Kathleen Sebelius — Page 6

Slew Lo Slyer,

Steven L. Simon, PhD

Dosimetry Unit Head

Radiation Epidemiology Branch

Division of Cancer Epidemiology and Genetics
National Cancer Institute

National Institutes of Health

Crm Gora,

C. Norman Coleman, MD
Associate Director
Radiation Research Program
National Cancer Institute
National Institutes of Health

OX We Suds 2a
Orhan Suleiman, MS, PhD, FAAPM
Senior Science Policy Advisor
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Attachments:

Petitioners’ Appeal Letter dated July 13, 2011



THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON, D.C. 20201

June 27, 2012

Dear Ms.

Thank you for your letter requesting an administrative review of my determination not to add a
class of employees from the Bliss & Laughlin Steel Company in Buffalo, New York to the
Special Exposure Cohort (SEC).

Pursuant to 42 CFR § 83.18(b), and because you filed a challenge of this determination,

I appointed a panel of three U.S. Department of Health and Human Services (HHS) personnel,
independent of the National Institute for Occupational Safety and Health (NIOSH), to conduct an
administrative review. The panel completed its review of the challenge.

After reviewing the administrative record in this case, the panel concluded that: (1) HHS
complied with the regulatory procedures set out in 42 CFR part 83; (2) my decision contained no
evidence of factual error and was supported by factually accurate information; and (3) there were
no errors of fact or omission in the principal findings and recommendations of NIOSH and the
Advisory Board on Radiation and Worker Health. In summary, the panel concluded that the’
challenge to my decision is without merit, and they have not recommended any change to my
decision to deny adding a class of Bliss & Laughlin employees to the SEC.

After review of the administrative review panel’s thorough report, I have decided not to revise
my June 3, 2011, final decision. I am enclosing a copy of the administrative review panel’s final
report to me. I will also provide this response to Ms. and Ms.

who cosigned your letter.

Sincerely,

Kathleen Sebelius

Enclosure


“* RECEIVED """

Jul 19,2011 11:49:57 WS# 20
OSNUM: 071920111060
OFFICE OF THE SECRETARY

CORRESPONDENCE
CONTROL CENTER.

Sincerely


"RECEIVED ***
‘ Jul 19,2011 11:49:57 WS# 20
OSNUM: 071920111060
OFFICE OF THE SECRETARY
CORRESPONDENCE
CONTROL CENTER:

completed and kept the records? What were the qualifications of the record keepers?
Why has this information been kept from claimants?

Ata time in Buffalo NY when job competition was keen, unemployment was high, and
“good” jobs were protected and coveted, wouldn’t it have been advantageous to make
sure the records did not negatively impact a laborer’s chance to earn a paycheck? It is
only common sense that the integrity of the monitoring data be severely scrutinized and
brought into question. May we please have a copy of the records, as they apparently are
so essential to your determination of your denial for Special Exposure Cohort?

What other sites has NIOSH obtained their information from on the air monitoring data
that was used to determine their decision regarding the Bliss & Laughlin Plant?

NIOSH has also stated that there is sufficient Bliss and Laughlin information to
determine external and internal radiation doses. What and where is this information? We
need to know this for all the same reasons stated earlier in this letter.

At the closing of the TBD-6000 Advisory Meeting of February 24, 2011, a statement
from one of the board members was made stating that Bliss & Laughlin “ran the rods for
only three days”. All along this process we have been advised that there were no records
available on the duration of this activity. We claimants need this information.
Specifically, where did this information come from? Why were claimants denied access
to it? Doesn’t it conflict with other data on the scope of the work performed at Bliss &
Laughlin? Does the “three day run” time frame cover all aspects of handling and work
from the time of the rods arrival to their departure from Bliss & Laughlin? The
information from NIOSH and HHS appear to be vastly different, if not contradictory, in
many categories. We believe this is an error that needs to be addressed.

On March 30, 2011, we researched our Buffalo & Erie County Main Library for more
concrete information, No information was available we were told, It was suggested that
we contact The Army Corp of Engineers. On May 4, 2011 The Army Corp of engineers
told us that 2 years after clean up of the Bliss and Laughlin Plant, that all site records are
sent to the Department of Energy. Did you access these records? We need access to these
records. If these records were not utilized, this is an error that must be addressed.

We feel that there are factual errors and substantial errors implementing your decision
that there are no records available with sufficient information. We feel that we were
dered information crucial to making our plea. These errors must be addressed.

How was it determined to be appropriate to compensate only 13 employees when all of
the employees reported to the Bliss and Laughlin Plant specifically to work on the
machining of these rods?

All Bliss & Laughlin employees contributed to this project, some with their very lives by
your own admission. How can you deny the remaining claimants access to the materials
and information essential to their compensation claims?


The Honorable Kathleen Sebelius — Page 5

are outside the scope of our review, we have attempted to respond to those questions that are
within our purview.

The petitioners’ letter set out three general categories of questions, as follows: (1) why some
Bliss & Laughlin employees were compensated and others were not; (2) how a determination
was made not to add Bliss & Laughlin employees to the SEC with limited or no monitoring
records ; and (3) whether petitioners could be provided with the records relied on in making the
determination,

In response to category (1) questions: This panel does not have access to information about the
compensation of individual workers, and determinations regarding individual compensation are
not within the scope of our charge to review your determination not to add a class of employees
to the SEC. Nonetheless, the very short time in which the Bliss & Laughlin workers milled
uranium rods was simply not long enough to impart enough radiation exposure to qualify for
compensation.

In response to category (2) questions: Although monitoring records may have been incomplete or
unavailable, the principles of dose reconstruction allow NIOSH to use other data to determine
doses received by Bliss & Laughlin employees. In cases where records were not maintained,
incomplete, or unavailable for this specific group of workers, the documents that we reviewed
make clear that NIOSH used measurement data from other sites that performed the same type of
work. These sites often had much greater workloads and, therefore the estimates were higher,
which resulted in a higher estimate of dose. Even with these higher estimates, the class of Bliss
& Laughlin workers still did not receive enough radiation to warrant compensation.

In response to category (3) questions: The documents relied upon in making your determination
were either transmitted to petitioners pursuant to the regulations (¢.g., the NIOSH Evaluation
report), presented at meetings which petitioners attended, posted on the NIOSH website, or have
been or will be provided to petitioners pursuant to a request under the Freedom of Information
Act. Thus, petitioners have received or have access to all of these records..

Finally, we note the petitioners’ overall concern: “All Bliss & Laughlin employees contributed to
this project, some with their very lives by your own admission. How can you deny the remaining
claimants access to the materials and information essential to their compensation claims?” Here,
we acknowledge the sacrifice that many such employees made during that period of time and we
express our sympathy to the claimants. However, we have articulated above that the data have
been made available to the claimants and, moreover, we have found the petitioners’ overall claim
to not be supported.



gene

SE

May 23, 2012

The Honorable Kathleen Sebelius
Secretary of Health and Human Services
Department of Health and Human Services
200 Independence Avenue, S.W,
Washington, DC 20201

RE: Bliss & Laughlin Special Exposure Cohort Administrative Review Panel
Dear Madam Secretary:

On June 3, 2011, as authorized under the Energy Employees Occupational IlIness Compensation
Act of 2000 (EEOICPA), 42 U.S.C. § 7384q(b), you determined that the following class of
employees does not meet the statutory criteria for addition to the Special Exposure Cohort
(SEC):

All Atomic Weapons Employees who worked at the Bliss & Laughlin Steel Company
located at 110 Hopkins Street, Buffalo, New York, for the period from January 1, 1951
through December 31, 1952 and/or during the residual period from January 1, 1953 through
December 31, 1998.

Pursuant to 42 U.S.C. § 7384q, a class may be designated for addition to the SEC if the Secretary
determines, upon recommendation of the Advisory Board on Radiation and Worker Health (the
Board), that: (1) it is not feasible to estimate with sufficient accuracy the radiation dose that the
class received; and (2) there is reasonable likelihood that such radiation dose may have

endangered the health of members of the class. The basis for your decision in this case was the
determination that it is feasible to reconstruct the radiation dose estimates encountered by Bliss

& Laughlin employees with sufficient accuracy; accordingly, a determination of health
endangerment was not required.

Ina letter dated July 13, 2011, petitioners

surviving daughters of a former employee at the Bliss & Laughlin Steel Company,
filed a challenge to your June 3, 2011, determination. A copy of petitioners’ appeal letter is
attached. EROICPA implementing regulations at 42 CFR § 83.18(a) provide that, in order to
contest a final decision by the Secretary to deny adding a class to the Cohort, a challenge “must
include evidence that the final decision relies on a record of either substantial factual errors or
substantial errors in the implementation of the procedures” set out in 42 CFR part 83. The
petitioners’ appeal letter states “We feel that there are factual errors and substantial errors
implementing your decision that there are no records available with sufficient information. We
feel that we were denied information crucial to making our plea, These errors must be
addressed.”



WASHINGTON, 0.C. 20201

June 27, 2012

Dear Ms.

Thank you for your letter requesting an administrative review of my determination not to add a
class of employees from the Bliss & Laughlin Steel Company in Buffalo, New York to the
Special Exposure Cohort (SEC).

Pursuant to 42 CFR § 83.18(b), and because you filed a challenge of this determination,

I appointed a panel of three U.S. Department of Health and Human Services (HHS) personnel,
independent of the National Institute for Occupational Safety and Health (NIOSH), to conduct an
adininistrative review. The panel completed its review of the challenge.

After reviewing the administrative record in this case, the panel concluded that: (1) HHS
complied with the regulatory procedures set out in 42 CFR part 83; (2) my decision contained no
evidence of factual error and was supported by factually accurate information; and (3) there were
no errors of fact or omission in the principal findings and recommendations of NIOSH and the
Advisory Board on Radiation and Worker Health. In summary, the panel concluded that the
challenge to my decision is without merit, and they have not recommended any change to my
decision to deny adding a class of Bliss & Laughlin employees to the SEC.

After review of the administrative review panel’s thorough report, I have decided not to revise
my June 3, 2011, final decision. I am enclosing a copy of the administrative review panel’s final
report to me. I will also provide this response to Ms. and Ms,

who cosigned your letter,

Sincerely,

Kathleen Sebelius

Enclosure



gpitiigy,
TO _ THE SECRETARY OF HEALTH AND HUMAN SERVICES

ihe,

gaMe?
se

WASHINGTON, D.C. 20204

June 27, 2012

Dear Ms.

Thank you for your letter requesting an administrative review of my determination not to add a
class of employees from the Bliss & Laughlin Steel Company in Buffalo, New York to the
Special Exposure Cohort (SEC),

Pursuant to 42 CFR § 83.18(b), and because you filed a challenge of this determination,

I appointed a panel of three U.S. Department of Health and Human Services (HHS) personnel,
independent of the National Institute for Occupational Safety and Health (NIOSH), to conduct an
administrative review. The panel completed its review of the challenge.

After reviewing the administrative record in this case, the panel concluded that: (1) HHS
complied with the regulatory procedures set out in 42 CFR part 83; (2) my decision contained no
evidence of factual error and was supported by factually accurate information; and (3) there were
no errors of fact or omission in the principal findings and recommendations of NIOSH and the
Advisory Board on Radiation and Worker Health. In summary, the panel concluded that the
challenge to my decision is without merit, and they have not recommended any change to my
decision to deny adding a class of Bliss & Laughlin employees to the SEC.

After review of the administrative review panel’s thorough report, I have decided not to revise
my June 3, 2011, final decision, I am enclosing a copy of the administrative review panel’s final
report to me. I will also provide this response to Ms. and Ms,

who cosigned your letter.

Sincerely,

Kathleen Sebelius

Enclosure